CTRI/2020/10/028511
Recruiting
Phase 1
Can cerebral oximetry by near-infrared spectroscopy predict clinical and radiological deterioration in conservatively managed traumatic brain injury patients? A prospective observational study.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- JIPMER
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •We will include non\-operatively managed, adult, TBI patients who present within 24 hours of trauma, and in whom the treating team anticipates a progression of CT findings or clinical deterioration in the next three days. This could be based on any combination of findings such as sizable contusions, acute subdural hematoma, and brain edema with partial or complete obliteration of cisterns. The decision will be made by the treating team. Since there are innumerable clinical situations, and due to the absence of level 1 (RCT) evidence for surgical decision making, we are not providing strict, exhaustive criteria, but we would like to leave it to the treating teamâ??s best judgment.
Exclusion Criteria
- •Patients who require immediate operative intervention as per judgment of the treatment team which is expected to follow the guidelines of the Brain Trauma Foundation. (The guidelines of the BTF for surgical intervention are not level 1 but are expert opinions themselves)
- •Patients who are planned for barbiturate coma or similar burst suppression techniques.
- •Pure diffuse axonal injury without edema or significant hematoma or cisternal obliteration where deterioration is only expected because of progressive axonal damage.
- •Pure brainstem contusions or pure posterior fossa hematomas.
- •A patient with traumatic great vessel dissection causing an infarct that is visible in the initial scan.
- •Patients who have multiple system injuries besides TBI, who could go into hypotension or hypoxia that could affect the rSO2 levels or who are already in hypotension or hypoxia due to any cause.
- •Patients who have large skin abrasion or laceration or contusion over the forehead, that prevents the application of the sensor electrodes
- •A patient with an extradural hematoma or a thick subdural hematoma (1 cm or more) or thick pneumocephalus (5 mm or more, confluent) overlying the frontal brain at the forehead area since the signal might be absorbed by the blood or air.
- •A patient with grossly depressed fracture at the forehead area
- •Patients who are in a poor neurological status that survival for a period of one week is deemed unlikely
Outcomes
Primary Outcomes
Not specified
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